ALDACTONE® How Supplied/Storage and Handling (spironolactone) | Pfizer Medical Information - US

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16 HOW SUPPLIED/STORAGE AND HANDLING

ALDACTONE 25 mg tablets are round, light yellow, film-coated, with SEARLE and 1001 debossed on one side and ALDACTONE and 25 on the other side, supplied as:

	NDC Number	Size
	0025-1001-31	bottle of 100

ALDACTONE 50 mg tablets are oval, light orange, scored, film-coated, with SEARLE and 1041 debossed on the scored side and ALDACTONE and 50 on the other side, supplied as:

	NDC Number	Size
	0025-1041-31	bottle of 100

ALDACTONE 100 mg tablets are round, peach-colored, scored, film-coated, with SEARLE and 1031 debossed on the scored side and ALDACTONE and 100 on the other side, supplied as:

	NDC Number	Size
	0025-1031-31	bottle of 100

Store below 77°F (25°C).

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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1 INDICATIONS AND USAGE

1.1 Heart Failure

ALDACTONE is indicated for treatment of NYHA Class III–IV heart failure and reduced ejection fraction to increase survival,...

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2 DOSAGE AND ADMINISTRATION

2.1 General Considerations

ALDACTONE can be taken with or without food, but should be taken consistently with respect to food...

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3 DOSAGE FORMS AND STRENGTHS

Tablets: 25 mg round, light yellow, film-coated, with SEARLE and 1001 debossed on one side and ALDACTONE and 25 on the other side.

Tablets: 50 mg oval, light orange, scored, film-coated,...

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4 CONTRAINDICATIONS

ALDACTONE is contraindicated in the patients with:

•: Hyperkalemia
•: Addison's disease
•: Concomitant use of eplerenone

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5 WARNINGS AND PRECAUTIONS

5.1 Hyperkalemia

ALDACTONE can cause hyperkalemia. This risk is increased by impaired renal function or concomitant potassium...

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6 ADVERSE REACTIONS

The following clinically significant adverse reactions are described elsewhere in the labeling:

•: Hyperkalemia [see Warnings and Precautions (5.1...

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7 DRUG INTERACTIONS

7.1 Drugs and Supplements Increasing Serum Potassium

Concomitant administration of ALDACTONE with potassium supplementation or drugs that can...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

Based on mechanism of...

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10 OVERDOSAGE

The oral LD50 of ALDACTONE is greater than 1000 mg/kg in mice, rats, and rabbits.

Acute overdosage of ALDACTONE may be manifested by drowsiness, mental confusion, maculopapular or...

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11 DESCRIPTION

ALDACTONE oral tablets contain 25 mg, 50 mg, or 100 mg of the aldosterone antagonist spironolactone, 17-hydroxy-7α-mercapto-3-oxo-17α-pregn-4-ene-21-carboxylic acid γ-lactone acetate, which has the following...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Spironolactone and its active metabolites are specific pharmacologic antagonists of aldosterone, acting primarily...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

...

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14 CLINICAL STUDIES

14.1 Heart Failure

The Randomized Aldactone Evaluation Study (RALES) was a placebo controlled, double-blind study of the effect of spironolactone...

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16 HOW SUPPLIED/STORAGE AND HANDLING

ALDACTONE 25 mg tablets are round, light yellow, film-coated, with SEARLE and 1001 debossed on one side and ALDACTONE and 25 on the other side, supplied as:

...

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17 PATIENT COUNSELING INFORMATION

Patients who receive ALDACTONE should be advised to avoid potassium supplements and foods containing high levels of potassium, including salt substitutes.

This product's label may have...

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Pfizer Safety

To report an adverse event related to Pfizer-BioNTech COVID-19 Vaccine (also known as COMIRNATY®, COVID-19 mRNA, Vaccine BNT162b2 or BNT162) or Pfizer COVID-19 Treatment (also known as PAXLOVID™ (nirmatrelvir tablets; ritonavir tablets)), and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at
(800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.